 |
 |
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA | FDA Centennial
This press release was revised May 23, 2006, to provide technical clarifications in the headline.
| FOR IMMEDIATE RELEASE |
Media
Inquiries: |
The U.S. Food and Drug Administration (FDA) is launching the Medical Device Innovation Initiative to make new medical devices available more quickly for patients. This broad initiative will promote early interaction between the FDA and industry to optimize review times and foster innovation. As outlined in a report released by the Agency today, the Center for Devices and Radiological Health (CDRH) will expand current efforts to promote scientific innovation in product development, focus device research on cutting edge science, modernize the review of innovative devices, and facilitate a least burdensome approach to clinical trials. This initiative builds on CDRH's strong scientific foundation and additional resources for the device review program provided under the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).
With the convergence of many scientific and technology breakthroughs, the pace of medical invention is accelerating, inspiring hope for better health outcomes with less invasive procedures and shorter recovery times. "We must keep up with the rapid developments in science and technology to ensure that patients have access to the most advanced treatments available," said FDA Acting Commissioner Andrew C. von Eschenbach, M.D. "By working with industry early in the evaluation process, we hope to foster development and speed up the approval of safe and effective innovative devices."
As part of this initiative, FDA also announced today a critical step forward in modernizing the medical device development process by issuing new guidelines to outline the use of adaptive clinical trial designs. The draft guidance titled, "Bayesian Statistics in Medical Device Clinical Trials", provides FDA's recommendations on the use of Bayesian statistical methods in the design and analysis of medical device clinical trials. "Although this guidance is not yet final, it is a very exciting move in the direction of expediting new technology to the public," said CDRH Director Daniel Schultz, M.D. The use of Bayesian statistics offers industry the option of using prior, legally available information about safety and/or effectiveness in a mathematically acceptable way to design more efficient clinical trials, while still maintaining scientific rigor. Depending on the type of data available, this may lead to shorter, less expensive clinical trials.
In addition to the introduction of the Bayesian Statistics Guidance, the Medical Device Innovation Report details the expansion of the following efforts to promote innovation and efficiency. Some critical aspects of the report are described as follows:
CDRH will provide a clearer pathway for innovators by prioritizing guidance development to discuss regulatory requirements and review procedures to increase the consistency and transparency of its review process. Guidance documents related to specific innovative medical products currently under development include drug eluting stents, combination device/biologic products for cartilage repair, and genetic and pharmacogenomic tests. To address today's technological advancements, FDA also intends to release an intercenter guidance document on innovative combination products.
CDRH is collaborating with outside groups to facilitate the availability of innovative medical devices in critical areas of unmet needs, such as pediatrics. Such research includes developing anatomically and physiologically accurate adult and pediatric virtual circulatory systems that can quantify the maximum load and stress forces for certain vascular stent devices. Other examples include developing animal models to improve prediction of toxic effects of medical products on critically ill patients, as well as a new statistical model for predicting the effectiveness of implanted cardiac stents.
Effective and on-going communication among FDA, industry, patients and clinicians is essential for fostering medical device innovation and ensuring transparency. CDRH is stepping up its efforts to expand these kinds of interactions during product development and premarket review in order to improve its tools for communicating medical information to consumers and healthcare providers once products are marketed. These tools include workshops for industry, participation in professional conferences, and an improved process for issuing public health notifications.
CDRH is focusing its laboratory expertise and resources to address challenging scientific issues that arise in considering new medical device technologies. The research findings help inform agency decision-making and ultimately help to expedite the availability of products with innovative breakthrough technology. Examples include using CDRH laboratory expertise in experimental and computational fluid dynamics to evaluate a pediatric cardiac device, as well as CDRH's development of new models and methods for the assessment of computer-assisted diagnostic systems.
CDRH has instituted an ongoing quality review program for premarket submissions to identify and apply best management practices internally. This program is intended to continue to assure we maintain high scientific quality for new treatments and diagnostics as we continue to reduce review times. This is accomplished by ensuring consistency among reviewers and by helping product sponsors submit applications that efficiently demonstrate the safety and effectiveness of the device.
CDRH is undertaking a number of initiatives that leverage the use of information technology (IT) to improve patient safety and make the development process more efficient. We are developing new IT systems that allow for better monitoring and tracking of premarket submissions and for improved communication and coordination among review teams.
With the additional resources from MDUFMA, CDRH is expanding its use of outside experts through the Medical Device Fellowship Program (MDFP). This expertise will assure that the Center remains current on the latest technological and clinical advances. Over the past two years, CDRH has hired experts in many critical areas, including Anesthesiology, Brachytherapy, Cardiothoracic Surgery, Electrophysiology, Human Factors Engineering, Neurosurgery, Nephrology, Pediatric Cardiology, Pulmonology, Radiation Oncology and Software Engineering. These experts will help FDA expedite the availability of new, cutting edge technology.
These exciting on-going initiatives will build on the successes of MDUFMA and further modernize the medical device review process in order to ultimately improve patient health and safety.
####
Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials
RSS Feed for FDA News Releases [what's this?]
Get
free weekly updates about FDA press releases, recalls, speeches, testimony
and more.